Corona Virus InfectionNCT04412551
Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
An observational study of Corona Virus Infection and Virus Diseases, run by Dalarna County Council, Sweden at 1 site in Sweden.
Trial summary
This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corona Virus Infection, Virus Diseases, Coronaviridae Infections
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- 20 May 2020to 31 Dec 2020
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adult patients with confirmed Covid-19 and oxygen therapy corresponding to stage 4-5 on the "Ordinal Scale for Clinical Improvement" of the World Health Organization.
Who may be able to join
- Covid-19 confirmed by positive polymerase chain reaction (PCR)
- oxygen by mask or nasal prongs ≥ 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) ≥ 30%
- age between 18-80 years
- informed consent
Who cannot join
- patients subject to treatment-limitation "no ICU"
- history of heart failure
- history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis
- history of kidney failure requiring dialysis
- any reason making lung ultrasound or daily follow up impossible
- opposition to participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
Read the detailed description
Study patients with moderate to severe Covid-19 infection will be screened with lung ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and consolidations will be noted. In addition to LUS, clinical parameters from physical examination and laboratory tests will be collected. Participants wil be followed until either admission to intensive care unit (ICU) for mechanical ventilation or until clinical improvement. A group of patients with mild Covid-19 infection will be recruited and screened once as reference.
Apart from assessment with LUS, patients are managed according to routine care.
- Keywords
- ultrasonography, lung ultrasound, covid-19, ARDS
- Medical subject headings
- Coronavirus Infections, Virus Diseases, Coronaviridae Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of requirement of mechanical ventilation
Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
Measured: 3 weeks
Secondary outcomes (3)
Prediction of requirement of mechanical ventilation
Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
Measured: 3 weeks
Association of LUS to clinical parameters
Descriptive assessment of clinical parameters and LUS-score over time
Measured: 3 weeks
Description of findings on LUS
Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start20 May 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hårdstedt, Dalarna County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412551
- Sponsor's protocol ID
- LUS-Covid001
- Status last verified
- May 2021
- First submitted
- 1 Jun 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.
PubMed 25501898
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
- ClinicalTrials.gov ID
- NCT04412551
- Acronym / sponsor ID
- LUS-Covid001
- Keywords
- ultrasonography, lung ultrasound, covid-19, ARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
Detailed description
Study patients with moderate to severe Covid-19 infection will be screened with lung ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and consolidations will be noted. In addition to LUS, clinical parameters from physical examination and laboratory tests will be collected. Participants wil be followed until either admission to intensive care unit (ICU) for mechanical ventilation or until clinical improvement. A group of patients with mild Covid-19 infection will be recruited and screened once as reference.
Apart from assessment with LUS, patients are managed according to routine care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients with confirmed Covid-19 and oxygen therapy corresponding to stage 4-5 on the "Ordinal Scale for Clinical Improvement" of the World Health Organization.
Key inclusion criteria (4 listed)
- Covid-19 confirmed by positive polymerase chain reaction (PCR)
- oxygen by mask or nasal prongs ≥ 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) ≥ 30%
- age between 18-80 years
- informed consent
Key exclusion criteria (6 listed)
- patients subject to treatment-limitation "no ICU"
- history of heart failure
- history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis
- history of kidney failure requiring dialysis
- any reason making lung ultrasound or daily follow up impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of requirement of mechanical ventilation
Time frame: 3 weeks
Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
3 secondary outcomes
Prediction of requirement of mechanical ventilation
Time frame: 3 weeks
Association of LUS to clinical parameters
Time frame: 3 weeks
Description of findings on LUS
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 25501898Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and Virus Diseases, run by Dalarna County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of requirement of mechanical ventilation (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04412551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.